Zymeworks Inc

Zymeworks is a publicly listed (NASDAQ:ZYME) clinical-stage biopharmaceutical company dedicated to the discovery, development and commercialization of next-generation, bispecific and multifunctional biotherapeutics, initially focused on the treatment of cancer.. Zymeworks is seeking a Sr. Clinical Data Manager to contribute to Clinical Data Management activities.. Performs DM lifecycle activities, from study start-up, maintenance, database lock and close-out.. Thorough knowledge of FDA regulations, ICH GCP guidelines, Good Clinical Data Management Practices, SDTM, CDISC, database development, user acceptance testing, medical coding, the drug development process.. Previous relevant electronic systems as such EDC, IXRS, RTSM. Medidata Rave preferred.

clinical data manager

Company Description Zymeworks is a publicly listed (NASDAQ:ZYME) clinical-stage biopharmaceutical company dedicated to the discovery, development and commercialization of next-generation, bispecific and multifunctional biotherapeutics, initially focused on the treatment of cancer. Zymeworks' suite of complementary therapeutic platforms and its fully-integrated drug development engine provide the flexibility and compatibility to precisely engineer and develop highly-differentiated product candidates. Why Work With Us Nothing is more critical to our success than the quality of our team. The work we do is meaningful and impactful - we care about each other as well as the patients we serve. We offer challenging career opportunities, competitive benefits and an environment that recognizes and rewards performance. Zymeworks is proudly headquartered in our brand new, net-zero facility located in the vibrant Main St biotech hub of Vancouver, BC, with operations in Bellevue, WA, Dublin, Ireland, Singapore and the Bay Area. About The Position Zymeworks is seeking a Sr. Clinical Data Manager to contribute to Clinical Data Management activities. This role will complete data management tasks with a high degree of quality in accordance with regulatory requirements and Zymeworks’ timelines. The Sr. Clinical Data Manager will have a thorough knowledge of FDA regulations and industry standards, strong technical skills, and capable of working independently and collaboratively, in addition to providing oversight of CRO activities. Work Requirement This position is open to qualified candidates in our San Francisco hub (Redwood City) and is eligible for our Hybrid Work Plan (3 days per week in office). The role will report to the Director, Data Management. Key Responsibilities <ul><li>Oversees/participates in clinical data management project activities performed by vendors/CROs to ensure activities are performed with the highest quality.</li><li>Represents Zymeworks on cross-functional teams for assigned studies.</li><li>Contributes to the development/review of relevant data management documentation, including but not limited to CRFs, CRF Completion Guidelines, Data Management Plans, Edit Check Specifications, Data Review Plans, Data Transfer Specifications, etc. </li><li>Performs DM lifecycle activities, from study start-up, maintenance, database lock and close-out. Activities include, but are not limited to, CRF development, edit check specifications development, User Acceptance Testing, query management, etc.</li><li>Leads study team in the data cleaning process in an efficient and timely matter.</li><li>Understands critical tasks and milestones to ensure data management deliverables are met per study timelines.</li><li>Maintains DM metrics, timelines, meeting agendas/minutes, etc.</li><li>Contributes to the continuous improvement of CDM processes, including development/updating of SOPs and Work Instructions.</li><li>Management of third-party data and corresponding reconciliations. </li></ul>Education And Experience <ul><li>BA or BS in a relevant field and a minimum of 8 years related experience or an equivalent combination of education and experience.</li><li>Thorough knowledge of FDA regulations, ICH GCP guidelines, Good Clinical Data Management Practices, SDTM, CDISC, database development, user acceptance testing, medical coding, the drug development process.</li><li>Previous relevant electronic systems as such EDC, IXRS, RTSM. Medidata Rave preferred.</li><li>Previous vendor/CRO oversight experience.</li><li>Preferred:</li><ul><li>Oncology experience</li><li>Previous experience with ePRO, SharePoint, J-Review, Business Intelligence tool</li><li>Database development experience</li><li>Programming experience </li></ul></ul>Skills And Abilities <ul><li>Proven interpersonal skills and the ability to work collaboratively as a member of cross functional team. Ability to establish and maintain effective working relationships.</li><li>Effective organizational skills and the ability to work effectively in a high paced, fast changing environment.</li><li>Ability to multi-task and prioritize.</li><li>Detail oriented; performs quality and accurate work.</li><li>Technologically savvy; ability to quickly learn and implement new information, standards, regulations, tools, methods, or software as it relates to position and profession. </li></ul>Total Rewards We offer a comprehensive total rewards package, which includes competitive salaries, generous benefits, an outstanding work environment, and excellent opportunities for professional growth. We regularly benchmark our compensation against leading biotechnology companies in our geographies. The US base salary range for this full time position is $113,000 - $173,000 + bonus + equity + benefits. Our salary ranges are determined by role, level, and location. The range displayed on each job posting reflects the minimum and maximum target for new hire salaries for the position across all Canadian locations. Within the range, individual pay is determined by a variety of factors and the salary offered may vary depending on the successful candidate’s location and qualifications (including, but not limited to, job-related knowledge, education, training, skills, and experience). Please note that the compensation details listed in role postings reflect the base salary only, and do not include bonus, equity, or benefits. Our Team Enjoys <ul><li>Industry leading vacation and paid time off</li><li>Excellent health and wellness benefits</li><li>Zymelife health and wellness benefits</li><li>Paid time off to volunteer in your community</li><li>Matching country specific pension savings program</li><li>Employee Share Purchase Program</li><li>Employee Equity Program </li></ul>All qualified applicants will receive consideration for employment without regard to race, colour, religion, sex, sexual orientation, gender identity, national origin or disability. NOTE TO AGENCIES: Zymeworks values our relationships with our recruiting partners. We only accept resumes from those partners who have been contracted with us. Zymeworks is not responsible for any fees related to resumes that are unsolicited or are received without contract.

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